Pain Relief PM ACETAMINOPHEN ASPIRIN DIPHENHYDRAMINE CITRATE CVS PHARMACY FDA Approved Uses for the temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness
FunFoxMeds bottle
Substance Acetaminophen
Route
ORAL
Applications
M013
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredients (in each caplet) Acetaminophen 250 mg Aspirin 250 mg (NSAID)* Diphenhydramine citrate 38 mg *nonsteroidal anti-inflammatory drug
Inactive Ingredients
Inactive ingredients corn starch crospovidone FD&C blue #1 aluminum lake hypromellose maltodextrin medium chain triglycerides microcrystalline cellulose polydextrose povidone sodium lauryl sulfate sodium starch glycolate sodium sulfate stearic acid talc titanium dioxide yellow iron oxide zinc stearate
Strengths
250 mg 38 mg
Treats Conditions
Uses For The Temporary Relief Of Occasional Headaches And Minor Aches And Pains With Accompanying Sleeplessness
Pill Appearance
Shape: oval Color: blue Imprint: 674

Identifiers & Packaging

Container Type BOTTLE
All Product Codes
UPC
0050428421772
UNII
362O9ITL9D R16CO5Y76E 4OD433S209
Packaging

Principal Display Panel ♥︎CVS Health® Compare to the active ingredients in Excedrin® PM Headache † Caplets Pain Relief PM ACETAMINOPHEN, 250 mg ASPIRIN (NSAID) , 250 mg DIPHENHYDRAMINE CITRATE, 38 mg Pain reliever, Nighttime sleep-aid • Non-habit forming • For pain with sleeplessness 100 CAPLETS Actual Size Package Contains One Bottle TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING † This product is not manufactured or distributed by GSK Consumer Healthcare SARL, owner of the registered trademark Excedrin® PM Headache. 50844 REV1121A67412 Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895 © 2022 CVS/pharmacy CVS.com® 1-800-SHOP CVS V-11112 CVS 44-674 CVS 44-674

Package Descriptions
  • Principal Display Panel ♥︎CVS Health® Compare to the active ingredients in Excedrin® PM Headache † Caplets Pain Relief PM ACETAMINOPHEN, 250 mg ASPIRIN (NSAID) , 250 mg DIPHENHYDRAMINE CITRATE, 38 mg Pain reliever, Nighttime sleep-aid • Non-habit forming • For pain with sleeplessness 100 CAPLETS Actual Size Package Contains One Bottle TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING † This product is not manufactured or distributed by GSK Consumer Healthcare SARL, owner of the registered trademark Excedrin® PM Headache. 50844 REV1121A67412 Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895 © 2022 CVS/pharmacy CVS.com® 1-800-SHOP CVS V-11112 CVS 44-674 CVS 44-674

Overview

Uses for the temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness

Indications & Usage

Uses for the temporary relief of occasional headaches and minor aches and pains with accompanying sleeplessness

Dosage & Administration

Directions do not take more than directed adults and children 12 years and over: take 2 caplets at bedtime, with a full glass of water do not take more than 2 caplets in 24 hours, unless directed by a doctor children under 12 years: do not use

Warnings & Precautions
Warnings Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness. Allergy alert: Aspirin may cause a severe allergic reaction, which may include: hives facial swelling shock asthma (wheezing) Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include: blisters rash skin reddening If a skin reaction occurs, stop use and seek medical help right away. Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 4,000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you are age 60 or older take more or for a longer time than directed take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others] have had stomach ulcers or bleeding problems take a blood thinning (anticoagulant) or steroid drug have 3 or more alcoholic drinks every day while using this product Do not use if you have ever had an allergic reaction to acetaminophen, aspirin, or any other pain reliever/fever reducer with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. with any other product containing diphenhydramine, even one used on skin in children under 12 years of age Ask a doctor before use if stomach bleeding warning applies to you you have a history of stomach problems, such as heartburn you have difficulty in urination due to enlargement of the prostate gland you have liver disease you have a breathing problem such as emphysema or chronic bronchitis you are taking a diuretic you have high blood pressure, heart disease, liver cirrhosis, or kidney disease you have glaucoma you have asthma Ask a doctor or pharmacist before use if you are taking a prescription drug for: diabetes gout arthritis any other drug, or are under a doctor’s care for any serious condition sedatives or tranquilizers any product that contains aspirin, acetaminophen, or any other pain reliever/fever reducer When using this product avoid alcoholic beverages drowsiness may occur do not drive a motor vehicle or operate machinery Stop use and ask a doctor if an allergic reaction occurs. Seek medical help right away. you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pain that does not get better ringing in the ears or a loss of hearing occurs sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness. pain gets worse or lasts for more than 10 days redness or swelling is present new symptoms occur These could be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery. Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Purpose

Purpose Pain reliever Pain reliever Nighttime sleep-aid

Do Not Use

Do not use if you have ever had an allergic reaction to acetaminophen, aspirin, or any other pain reliever/fever reducer with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist. with any other product containing diphenhydramine, even one used on skin in children under 12 years of age

When Using

When using this product avoid alcoholic beverages drowsiness may occur do not drive a motor vehicle or operate machinery

Stop Use & Ask a Doctor

Stop use and ask a doctor if an allergic reaction occurs. Seek medical help right away. you experience any of the following signs of stomach bleeding: feel faint vomit blood have bloody or black stools have stomach pain that does not get better ringing in the ears or a loss of hearing occurs sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness. pain gets worse or lasts for more than 10 days redness or swelling is present new symptoms occur These could be signs of a serious condition.

Keep Out of Reach of Children

Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Storage & Handling

Other information store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) see end flap for expiration date and lot number

Questions

Questions or comments? 1-800-426-9391


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